Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations)

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Process Validation (Blend Uniformity/Content Uniformity)
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4
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11,780
v9991
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New FDA Guidance document released for Promotional Material, Labeling, etc
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1
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1,964
MIREGMGR
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Pharmaceutical Company Quality Manual
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6
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15,283
M Tanveer
AnaMariaVR2
GMP News: New Version of ISO 19011 on Auditing published
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2
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1,817
AnaMariaVR2
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Pharmaceutical Company - Water Requirements
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5
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2,008
gsinghgkp
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Handling Out-of-Specification Results: FDA's guidance for the industry
2
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12
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11,182
v9991
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Should the Line Clearance include Machine Setup for current Operation?
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3
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3,772
JaxQC
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Software Program Development GAMP Requirements
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1
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1,886
sagai
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FDA Position about Stainless Steel & Ra?
2
Replies
17
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23,717
v9991
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How to respond to a Regulator regarding missed corrective action timelines
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6
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2,722
v9991
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Expiry Date for Medicines and Foods
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3
Views
2,155
v9991
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Drug Products - Packaging and Labeling Operations Requirements - 211.130
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1
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2,913
tamale
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Consumables Certificates Classifications
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3
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1,977
Lugog
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What are the differences between US and EU Pharmacopeias?
2
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11
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5,371
Ajit Basrur
A
"GMP Area" - FDA definition
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3
Views
7,375
lameehan
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